Frequently Asked Questions About Lupus and BENLYSTA

Find answers to commonly asked questions about lupus and BENLYSTA.

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If you’re looking for additional support, the BENLYSTA Cares Support Team can help.

Call 1-877-4-BENLYSTA (1-877-423-6597) Monday to Friday, 8 AM to 8 PM ET.

For any medical questions or concerns, please contact your doctor.

  • What are some common symptoms of lupus?

    Since lupus can affect many different parts of the body, it can cause a lot of different symptoms, and these symptoms may come and go. Also, symptoms may vary from one patient to the next.

    The most common signs and symptoms of lupus include fatigue (feeling tired often), fever, joint pain, stiffness and swelling, butterfly-shaped rash on the cheeks and bridge of the nose or rashes elsewhere on the body, sun sensitivity, fingers and toes that turn white or blue when exposed to cold or during stressful periods (Raynaud's phenomenon), shortness of breath, chest pain, dry eyes, headaches, and confusion and memory loss.

    BENLYSTA may not help with all of these symptoms. Talk to your doctor to discuss your symptoms.

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  • What is systemic lupus erythematosus (SLE)?

    Systemic lupus erythematosus (SLE) is a systemic autoimmune disease caused by your body's immune system attacking your own tissues and organs. Inflammation caused by lupus can affect many different body systems, including your joints, skin, kidneys, blood cells, brain, heart, and lungs.

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  • What is lupus nephritis?

    When lupus causes the immune system to attack and inflame your kidneys, it’s called "lupus nephritis." This inflammation can make your kidneys unable to properly remove waste from your blood or control the amount of fluids in your body.

    Lupus nephritis most often develops within 5 years after a lupus diagnosis. Talk to your doctor about the impact of lupus nephritis on your kidneys and strategies to monitor disease progression.

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  • Who can get lupus? Do only women have lupus?

    Anyone can get lupus, but about 9 out of 10 cases of lupus are in women ages 15 to 44.

    Lupus is more common in women of color (African American, Hispanic, Asian, and Native American and Alaskan Native women). Researchers think that genes play a role in how lupus affects minority women.

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  • What are the common symptoms of lupus nephritis?

    In the early stages of lupus nephritis, symptoms may not be apparent. If you see any of these common signs and symptoms, contact your doctor right away:

    • Sudden and unexplained swelling, especially in the extremities (feet, ankles, legs, fingers, arms) or the eyes
    • Blood in the urine
    • Elevated blood pressure
    • Foamy or frothy urine
    • Increased need to urinate, especially at night

    Please note that this is not a complete list of all possible lupus nephritis symptoms. BENLYSTA may not help with all of these symptoms. Talk to your doctor to discuss your symptoms.

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  • Who can get lupus nephritis?

    Lupus nephritis most often develops within 5 years after a lupus diagnosis. Approximately 40% of people with lupus will develop lupus nephritis.

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  • If I have questions about taking BENLYSTA, whom can I talk to?

    You can ask your doctor or pharmacist for information about BENLYSTA. The BENLYSTA Cares Nurse Support Team* can also answer general questions about your treatment and provide you with additional resources to help with your lupus treatment.

    Call 1-877-4-BENLYSTA (1-877-423-6597), Monday to Friday, 8 AM to 8 PM ET.

    *Nurses from BENLYSTA Cares do not give medical advice and will direct you to your healthcare provider for any disease-, treatment-, or referral-related questions.

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  • What kind of medicine is BENLYSTA?

    BENLYSTA (belimumab) is a biologic therapy, not a steroid. It is taken in addition to your other lupus medications and is available in 3 options for adults with lupus and lupus nephritis:

    • An autoinjector you self-inject
    • A prefilled syringe you self-inject
    • An intravenous (IV) infusion a healthcare provider administers

    For children ages 5 and above with lupus or lupus nephritis, BENLYSTA is available as an IV infusion.

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  • How does BENLYSTA work?

    In people with lupus, certain white blood cells called autoreactive B cells (cells that react against the body) stay in the body longer than they should. 

    One of the important proteins for the growth of these B cells is called B-lymphocyte stimulator, or BLyS. BENLYSTA works by binding to BLyS. When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells.

    Get More Information on How BENLYSTA Works

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  • Who might be a candidate for treatment with BENLYSTA?

    BENLYSTA is not for everyone.

    Ask your doctor if BENLYSTA is right for you. Here are a few factors you and your doctor should discuss before prescribing BENLYSTA:

    • You have already been diagnosed with lupus and/or lupus nephritis
    • You are currently taking medicines to help manage your lupus and/or lupus nephritis
    • Your lupus and/or lupus nephritis has continued to be active 

    Remember, only you and your doctor can decide whether BENLYSTA is right for you.

    Other information to consider

    • It is not known if BENLYSTA is safe and effective in people with severe active central nervous system lupus, in children under 5 years of age when given in a vein (intravenously), or in children under 18 years of age when given under the skin (subcutaneously).

    BENLYSTA and pregnancy

    • Before you receive BENLYSTA, tell your doctor if you are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby.
    • You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA.
      • Tell your doctor right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.
    • If you become pregnant while receiving BENLYSTA, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.
    • Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed.

    This is not the full list of the items your healthcare professional will need to consider before prescribing BENLYSTA. For more information, refer to the Medication Guide for BENLYSTA and talk to your doctor.

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  • I'm currently receiving monthly BENLYSTA IV infusions. Can I switch to the autoinjector?

    You may be a candidate for BENLYSTA at-home administration with the autoinjector. Talk to your doctor to see if switching to the BENLYSTA autoinjector is right for you.

    If you and your doctor decide that you should switch, contact the BENLYSTA Cares Support Team to start the process through BENLYSTA Gateway.

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  • Can I take BENLYSTA if I am pregnant or plan to become pregnant?

    Before you receive BENLYSTA, tell your doctor if you are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby.

    You should talk to your doctor about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control for at least 4 months after the final dose of BENLYSTA.

    Tell your doctor right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.

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  • What is the most important information I should know about BENLYSTA?

    Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these side effects may cause death. Please see Prescribing Information and Medication Guide for BENLYSTA.

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  • Can I stop taking my other medicines while on BENLYSTA?

    Talk to your doctor. You should not make any changes in your medication regimen without first consulting your doctor. BENLYSTA is a prescription medication, given as an IV infusion or subcutaneous (SC) injection, for adults with active systemic lupus erythematosus (SLE) or active lupus medicines. BENLYSTA IV is approved in children ages 5 years and older with lupus or lupus nephritis or other lupus medicines. It is not known if BENLYSTA is safe and effective in people with severe active central nervous system lupus.

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  • Is BENLYSTA a steroid?

    BENLYSTA is a biologic therapy, not a steroid. It's the only FDA-approved treatment that targets BLyS, an underlying cause of lupus.

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  • How is BENLYSTA administered?

    For children ages 5 and above and adults, BENLYSTA can be administered by your healthcare provider through an IV infusion

    For adults, BENLYSTA can also be self-injected once a week through an SC injection, either with an autoinjector or a prefilled syringe.

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  • How many patients were included in the clinical trials for BENLYSTA?

    BENLYSTA has the largest lupus clinical trial program. BENLYSTA has been studied in multiple lupus clinical trials involving more than 2,500 adult patients, over 1,100 of whom were treated with BENLYSTA. To date, the pediatric program has included 93 children with lupus. BENLYSTA was also studied in the largest lupus nephritis clinical trial ever conducted, which involved 448 adult patients.

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  • What are the most common side effects of BENLYSTA?

    The most common side effects of BENLYSTA include nausea, diarrhea, fever, stuffy or runny nose and sore throat (nasopharyngitis), persistent cough (bronchitis), trouble sleeping (insomnia), leg or arm pain, depression, headache (migraine), pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

    These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    Risks and Side Effects

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  • Can BENLYSTA have serious side effects?

    Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these may cause death.

    • Infections
      Infections could be serious, leading to hospitalization or death.
    • Allergic (hypersensitivity) reactions
      Serious allergic reactions can happen the day of, or in days after, receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA given in a vein (intravenous infusion) and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your doctor right away if you have any symptoms of an allergic reaction.
    • Mental health problems and suicide
    • Progressive multifocal leukoencephalopathy (PML)
      PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as the following, tell your doctor right away: memory loss; trouble thinking; dizziness or loss of balance; difficulty talking or walking; loss of vision.
    • Cancer
      BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

    Please see Prescribing Information and Medication Guide for BENLYSTA for additional information.

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  • Is BENLYSTA a chemotherapy?

    No, BENLYSTA is not chemotherapy – it's a biologic therapy, delivered either through an IV infusion or as a self-injection. It works by reducing certain cells in your immune system that can make lupus active.

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  • Will my insurance or Medicare cover the cost of BENLYSTA?

    Each insurance policy is different and costs depend on your individual plan.

    To understand your cost for BENLYSTA, contact your insurance company or call the BENLYSTA Cares Support Team at 1-877-4-BENLYSTA (1-877-423-6597) Monday to Friday, 8 AM to 8 PM ET. The Support Team can connect you to BENLYSTA Gateway, which is part of BENLYSTA Cares, to research your estimated cost for BENLYSTA under your insurance policy.

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  • What is the BENLYSTA Co-pay Program?

    Pay as little as $0 for BENLYSTA.* The BENLYSTA Co-pay Program helps eligible commercially insured patients with their out-of-pocket costs for BENLYSTA up to $15,000 for 12 months. Work with your doctor to apply for the program through BENLYSTA Gateway or visit BENLYSTACopayProgram.com to apply.

    *Eligibility restrictions and program maximums apply. Visit www.GSKCopayPrograms.com for complete Program Terms and Conditions.

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  • Who is eligible for the BENLYSTA Co-pay Program?

    Eligibility criteria

    Patients may be eligible based on general eligibility criteria below: 

    • Patient has a commercial medical or prescription insurance plan; or 
    • Patient is uninsured;

    AND

    • Patient is a resident of the US (including the District of Columbia, Puerto Rico, and the US Virgin Islands); and
    • Not eligible for or enrolled in a government-funded program that provides prescription drug coverage*

    *Patients are not eligible for this program if they are covered by any federal or state prescription insurance program. This includes patients enrolled in Medicare Part B, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD) programs or TriCare. This may also include state pharmaceutical assistance programs and other federal or state plans not listed. Patients are also ineligible for this program if they are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. Patients enrolled in a state or federally funded prescription insurance program may not use this program even if they elect to be processed as an uninsured (cash paying) patient. Those on Medicare Part D, even if in the coverage gap, are not eligible.

    Additional program rules apply. Visit www.GSKCopayPrograms.com for complete Program Terms and Conditions.

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